To Evaluate add-on Effect of Nisha-Amalaki Tablets Along With Insulin on Glycemic Control in Type 1 Diabetes Patients (RCTNA)

Pilot Randomized Controlled Trial to Evaluate add-on Effect of Amalaki (Phyllantus Emblica) and Haridra (Curcuma Longa) Along With Insulin on Glycaemic Control in Patients With Type-I Diabetes Mellitus.

Type-I diabetes mellitus (T1DM) is an autoimmune condition, in which the pancreas reduces/stops insulin production. Patients with T DM have to take insulin injections with every meal and also usually a long-acting preparation. In India, approximately 8.6 lakh people suffer from T1DM, and one in six young patients dies without a diagnosis.

Significant advancements are being made in the field of T1DM research, including stem cell therapy, islet cell transplantation, and immunotherapies, which hold promise for the future. However, so far, there is no known permanent cure for T1DM. Thus, treatment of T1DM aims at maintaining normal blood sugar levels through regular monitoring, insulin therapy, diet, and exercise.

Dietary constituents play an important role in the management of T1DM. Studies have shown that the fruits of Phyllanthus emblica Linn, colloquially known as Indian gooseberry (amla), and/or some of its important constituents (including gallic acid, gallotanin, ellagic acid, and corilagin) possess anti-diabetic actions through their antioxidant and free-radical-scavenging properties. Amla has also been reported to prevent or reduce hyperglycemia, cardiac complications, diabetic nephropathy, neuropathy, cataract genesis, and protein wasting. However, clinical trial data with human subjects are limited and preliminary.

Numerous studies also report that turmeric (Curcuma longa) has antioxidant, anti-inflammatory, and anti-diabetic activities and can lower lipid levels. The hypoglycaemic effect of turmeric may be due to increased peripheral glucose utilization, decreased hepatic glucose synthesis, and/or increased insulin secretion.

In Ayurveda, the combination of turmeric (haridra) and amla (amalaki) is strongly recommended for Prameha (Diabetes mellitus).

Study Overview

• Status: Active, not recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Drug: inj insulin to one group; Drug: Inj Insulin with Tab Nisha-Amalaki 500 mg twice a day

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Pune, Maharashtra, India, 411001
      • Hirabai Cowasji Jehangir Medical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. K/C/O type-I DM for more than 1 year
2. Age above 10 years, (10-18 years) irrespective of sex, religion, and economic status
3. Parents provide consent and children providing assent for the study

Exclusion Criteria:

1. K/C/O type-I DM for more than 1 year
2. Age above 10 years, (10-18 years) irrespective of sex, religion, and economic status
3. Parents provide consent and children providing assent for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm1-Only insulin treatment for type 1 Diabetes patients; Arm1:-Insulin treatment- 4 times a day (Basal Bolus insulin) Inj Actrapid from Novo-Nordisk company and Inj Lantus from Sanofi company given as per body weight of patient for 3 months.	Drug: inj insulin to one group; One group- only inj insulin for 3 months.; Other Names: Inj Insulin; Drug: Inj Insulin with Tab Nisha-Amalaki 500 mg twice a day; second group- Inj Insulin with Tab Nisha-Dhatri 500 mg twice a day
Active Comparator: Arm2-Insulin with Nisha-Amalaki tablets; Arm2:-Insulin treatment- 4 times a day (Basal Bolus insulin) Inj Actrapid from Novo-Nordisk company and Inj Lantus from Sanofi company given as per body weight of patient with Tab Nisha-Amalaki Dhootpapeshwar GMP certified 500 mg twice a day for 3 months.	Drug: inj insulin to one group; One group- only inj insulin for 3 months.; Other Names: Inj Insulin; Drug: Inj Insulin with Tab Nisha-Amalaki 500 mg twice a day; second group- Inj Insulin with Tab Nisha-Dhatri 500 mg twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic control (HbA1c)	Change in glycemic control will be assessed using glycated hemoglobin (HbA1c) by standardized assays.	3 months
Change in a insulin dose	Change in an insulin dose will be assessed at baseline and after 3 months of intervention by administering a standardised questionnaire.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in urinary parameter.	Change in urinary parameter will be assessed by doing albumin:creatinine ratio(ug/mg)	3 months
Change in blood parameter-lipid profile.	Chane in cholesterol(mg/dl), triglycerides(mg/dl),Low density Lipoprotein(mg/dl)	3 months
Change in Fat (%)	Change in Body composition by using Bioelectrical Impedance Analysis(BIA)	3 months
Change in Body composition.	Change in fat mass ( kg) by using Bioelectrical Impedance Analysis(BIA)	3 months

Collaborators and Investigators

• Sponsor: Hirabai Cowasji Jehangir Medical Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: July 3, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: October 1, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Type-I diabetes mellitus; Haridra; Amalaki; Prameh
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: JCDC/BHR/24/032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No